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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name laser, ophthalmic
510(k) Number K072823
Device Name MERILAS 532A
Applicant
MERIDIAN AG
13 RED FOX LN.
LITTLETON,  CO  80127
Applicant Contact Kevin Walls
Correspondent
MERIDIAN AG
13 RED FOX LN.
LITTLETON,  CO  80127
Correspondent Contact Kevin Walls
Regulation Number886.4390
Classification Product Code
HQF  
Date Received10/02/2007
Decision Date 12/14/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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